QMS Software for Clinical and Medical Laboratories

Ensure regulatory compliance and efficacy in your laboratory’s operations.

Assure compliance in your clinical and medical laboratories

Like many other life science companies, clinical and medical laboratories must comply with complex regulatory requirements. Namely, Clinical Laboratory Improvement Amendments (CLIA), ISO 17025, ISO 15189, cGMPs, cGLPs, FDA regulations, such as the 21 CFR Part 11, and others. Compliance with these requirements can be achieved much easier and faster with laboratory quality management software from SimplerQMS.

Single platform that connects all quality processes

Laboratory quality management system software connects information across all quality processes in your clinical or medical laboratory, as well as other departments in the organization. Easily integrate processes such as document control, change control, personnel training, customer complaints, occurrence management, and other processes within your company.

QMS Integrated Processes
Automated Document Workflow illustration

Automate laboratory management processes

SimplerQMS’s software solution allows you to automate and manage various quality processes more efficiently. Laboratory QMS system software automates data collection, task assignments, scheduling, follow-ups, as well as creation, review, approval, escalation of document-based processes, and allows you to sign documents with the FDA 21 CFR Part 11 compliant electronic signatures.

This means no more chasing for signatures and manual circulation of documents in your organization.

Store everything in a centralized location

To this day many clinical and medical laboratories keep their documentation in physical binders. This usually results in multiple copies of the same document in various locations, which makes updating such documents error-prone and time-consuming. SimplerQMS’s laboratory quality management software stores all data in highly secure Microsoft Azure cloud storage allowing you to quickly access necessary documentation from anywhere.

Centralized Data Storage Illustration
Microsoft Office Interface

Simplify your document control processes

Document control is one of the most essential processes to assure safety and consistent operations for any clinical and medical laboratory. SimplerQMS laboratory document control software module allows you to send documents through an automated workflow for authoring, review, and approval processes. All documents are automatically named, numbered, and versioned, in a specific way that is compliant with accreditations. Furthermore, SimperQMS seamlessly integrates with the familiar Microsoft Office applications – Word, Excel, Outlook, and PowerPoint.

Avoid time-consuming software validation processes

The FDA 21 CFR Part 11 and GxP guidelines require computer system validation to ensure the integrity of electronic records and signatures.

To help you attain compliance SimplerQMS provides a pre-validated laboratory quality management software solution that fulfills the computer system validation requirements. This lowers the software deployment costs and time resources when compared to legacy QMS software solutions, allowing you to focus on more value-adding processes.

Life Science Validation Requirements
What kind of validation documentation and evidence do you provide?
  • Validation Procedure
  • Validation Plan
  • Validation Report
  • IQ, OQ and PQ Documentation
Trusted and Secure Platform

Secure QMS solution for laboratories

The SimplerQMS laboratory QMS software is built on M-Files and Microsoft technology ensuring a highly secure and trusted software solution, used by thousands of organizations worldwide. M-Files Document Management platform serves as a core of SimplerQMS quality management software. Microsoft Azure Cloud storage solution is used to store all your documents in the cloud.

Streamline your laboratory quality management processes

From document control with the FDA 21 CFR Part 11 compliant electronic signatures, time-stamped audit trails, and automated workflows to occurrence management and assessments. SimplerQMS helps you follow all laboratory quality management system essentials to ensure consistent, high-quality operations.

Organization and personnel

SimplerQMS allows you to implement organizational structures for access controls and organization-level quality principles without the need for a separate system. Ensure that the laboratory manager is connected to all the necessary processes, procedures, documents, and records – such as job descriptions and personnel training certificates.

Organizational Chart
Equipment calibration monitoring

Equipment management

Streamline your calibration activities to ensure that equipment in your laboratory operates as intended. With SimpelrQMS you can easily maintain complete calibration data, automatically trigger notification before the calibration due date, set up reminders, etc.

Purchasing and inventory management

Simplify your supplier selection processes by automating the evaluation and qualification of the supplier against different performance criteria. Maintain a list of approved suppliers and provide forms for recording contracts, surveys, certificates, and supplier evaluations.

Man pushing a trolley
Process control documents

Process control

SimplerQMS helps you monitor and adjust processes to get the desired output. For example, laboratory managers can generate sample recognition labels. The label information can be easily customized according to the requirements of your laboratory. The title can be traced back to the original sample to prevent misuse.

Document and record control

Streamline your document flow by automating data collection, generating documents based on approved formats, and sending documents through an automated workflow for authoring, review, and approval processes.

Document Approval Workflow
Document with magnifying glass

Occurrence and assessment management

Track the current state of “occurrences” or non-conformances, easily detect issues, and streamline the investigation back to their root cause to prevent a recurrence. With SimplerQMS you can also automate audit-related activities, reduce the time and effort needed to pass audits successfully.

Process improvement

With our training management capabilities, you can efficiently handle all processes from planning training to execution and produce significant improvements to your internal laboratory processes.

Continuous Improvement model
Customer Service Reviews

Customer service

With SimplerQMS you can track, manage, analyze and resolve complaints, all in one system. This allows you allows you to provide better customer service, understand their needs and use their feedback for further product and customer service improvements.

Facilities and safety

With SimplerQMS it’s much easier to conduct personnel training, from planning to execution, maintain an up-to-date set of procedures to a assure safe and clean laboratory environment.

Woman in a Laboratory Environment

What customers achieve with SimplerQMS

Utilize proven technology

SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.

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Pass audit more easily

Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.

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Gain a high level of traceability

Gain cross-functional visibility and trace back to the root cause of each nonconformance.

“The chance of a human error in the process of filling out documents has been reduced. There are several different human errors that have been eliminated and we feel like the system helps us to catch possible human errors more easily.”

Christian Schärfe Thomsen

Project Manager, Cortex

Ready to learn more?

To learn how you can make the most of SimplerQMS’s laboratory quality management system software, book a personalized demo.

SimplerQMS Demo Interface